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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: US-EPA § 163.81-4, “Primary eye irritation study”, Federal Register, Vol 43, No. 163, August 22, 1978
Deviations:
yes
Remarks:
lack of test material details, observation period only 7 days
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Housing: animals were housed individually in metal cages
- Diet: standard rabbit food - NAFAG, No. 814 (Gossau SG), ad libitum
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 10/10

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7days
Reading time points:
1, 2, 3, 4 and 7 days
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: in 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 mL of physiological saline.
- Time after start of exposure: 30 seconds

SCORING SYSTEM: Draize scoring system and primary irritation index

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
1.11
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals without rinsing
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
2.78
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
The individual results of the eye irritation test after 24, 48 and 72 h are listed in Table 1. In general, rinsing of the eye following instillation was of low or no effect (see Table 1 under "Any other information on results incl. tables").
Cornea: After 4 days scattered or diffuse area in 3/6 animals and easily discernible translucent areas 3/3 animals were observed. After 7 days 2/6 animals showed scattered or diffuse area and 4/6 animals showed easily discernible translucent areas.
Iris: After 4 days 1/6 animals and after 7 days 2/6 animals (all from the group without rinsing) showed folds above normal, congestion, swelling, circumcornea injection (any or all of these or combination of any thereof) iris still reacting to light.
Conjunctivae:Redness: All animals showed diffuse beefy redness after 4 and 7 days. After 4 days obvious swelling with partial eversion of lids was observed in 4/6 animals and swelling with lids about half closed in 2/6 animals (group without rinsing). After 7 days in all animals obvious swelling with partial eversion of lids was still apparent.
Discharge: After 4 days, discharge with moistening of the lids and hairs just adjacent to lids was observed in 4/6 animals, discharge with moistening of the lids and hairs, and considerable area around the eye was observed in 1 animal of the group without rinsing. In 1 animal (rinsing group) only slight discharge was observed. After 7 days, 2/6 animals showed slight discharge, and 3/6 animals still moderate and 1 animal (without rinsing group) discharge with moistening of the lids and hairs, and considerable area around the eye.
Other effects:
No further local or systemic effects were reported.

Any other information on results incl. tables

Table 1. Results of eye irritation study.

Rabbit #

Time [h]

conjunctivae

 

iris

cornea

redness

swelling

407
not rinsed

24

3

3

0

1

48

3

3

0

1

72

3

3

0

1

average

3,0

3,0

0,0

1,0

408
not rinsed

24

3

3

0

1

48

3

4

0

1

72

3

4

0

0

average

3,0

3,7

0,0

0,7

409
not rinsed

24

3

3

0

1

48

3

3

0

1

72

3

3

0

2

average

3,0

3,0

0,0

1,3

410 rinsed

24

3

3

0

1

48

3

2

0

1

72

3

2

0

2

average

3,0

2,3

0,0

1,3

411 rinsed

24

3

3

0

1

48

3

2

0

1

72

3

2

0

1

average

3,0

2,3

0,0

1,0

412 rinsed

24

3

3

0

1

48

3

2

0

1

72

3

2

0

2

average

3,0

2,3

0,0

1,3

 

Time [h]

conjunctivae

Iris

cornea

 

redness

swelling

 

 

average
score

24

3,00

3,00

0,00

1,00

48

3,00

2,67

0,00

1,00

72

3,00

2,67

0,00

1,33

24+48+72

3,00

2,78

0,00

1,11

Applicant's summary and conclusion

Interpretation of results:
other: Eye damage 1, H318. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).
Conclusions:
In the present study irreversible effects within a shorter observation period were observed in all animals. Classification as Category 1 was based on an expert judgement considering a worst case assumption.